NuVasive Inc. (Nasdaq: NUVA), a medical device company focused on the spine, announced the first ever FDA 510(k) clearance of a cervical corpectomy cage.
The X-Core Mini Cervical Corpectomy System is an expandable titanium vertebral body replacement device designed to provide enhanced stability following a corpectomy procedure. This clearance further showcases NuVasive's commitment to investing in innovative technology and clinical research to improve patient outcomes.
The NuVasive X-Core Mini Cervical Expandable VBR System (X-Core Mini VBR) is a vertebral body replacement device indicated for use in the cervical spine (C3-C7 vertebral bodies) in skeletally mature patients to replace a diseased or damaged vertebral body caused by tumor, fracture or osteomyelitis, in addition to the reconstruction following a corpectomy performed to achieve decompression of the spinal cord and neural tissues in cervical degenerative disorders.
X-Core Mini VBR is intended to be used with supplemental fixation cleared by the FDA for use in the cervical spine. These implants are intended for use with autograft or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft, as an adjunct to fusion. It is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion, with bone graft used at the surgeon's discretion.
X-Core Mini must be used with supplemental fixation cleared by the FDA for use in the cervical spine, which includes NuVasive's newly released Archon Reconstruction Corpectomy plate.
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